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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Jan. 20, 2017

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Number of U.S. Women Taking Maternity Leave Is Unchanged Over Two Decades There has been little change over the past two decades in the number of American women who take maternity leave, a new study finds. Between 1994 and 2015, the average number of women who took maternity leave each month remained at about...

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Best Ways to Steer Clear of the Flu

Posted today in Medical

SATURDAY, Jan. 21, 2017 -- The best way for people to protect themselves from the flu is to get vaccinated -- and it's not too late to get a shot, an infectious diseases expert says. The flu vaccine also protects those who aren't able to get it, including infants younger than 6 months and people with certain allergies and medical conditions, said Dr. Jeffrey Kahn. He is chief of pediatric infectious diseases at UT...

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Stress May Explain Digestive Issues in Kids With Autism

Posted yesterday in Medical

FRIDAY, Jan. 20, 2017 -- Many children with autism suffer from gastrointestinal problems, such as belly pain and constipation. And new research suggests that these issues may stem from a heightened response to stress. "When treating a patient with autism who has constipation and other lower gastrointestinal issues, physicians may give them a laxative to address these issues," said study author Dr. David...

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Ebola Blood Test May Help Predict Survival Chances

Posted yesterday in Medical

FRIDAY, Jan. 20, 2017 -- A blood test may help determine a person's chance of surviving an Ebola infection, researchers say. "It is not just defining how much Ebola virus that is present in a patient that defines whether a patient will survive. How the patient fights the infection is also key," said John Connor, an associate professor of microbiology at Boston University School of Medicine. Figuring out common...

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Flu Cases Starting to Spread: CDC

Posted yesterday in Medical

FRIDAY, Jan. 20, 2017 -- Flu activity continues to rise across the United States and there's been a slight uptick in the number of deaths in the last week, federal health officials reported Friday. The U.S. Centers for Disease Control and Prevention says it's still not too late to get a flu shot. That's particularly important for the most vulnerable -- the very young, the elderly, the chronically ill and pregnant...

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Allergan Announces FDA Approval of Rhofade (oxymetazoline hydrochloride) Cream for Facial Erythema Associated with Rosacea

Posted 2 days ago in New Drug Approvals

DUBLIN, Jan. 19, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, announced today the approval of Rhofade cream by the U.S. Food and Drug Administration (FDA) for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29.1 "The FDA...

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FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation

Posted 2 days ago in New Drug Approvals

January 19, 2017 -- The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients. “No one medication works for all patients suffering from chronic gastrointestinal disorders,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “With the availability of n...

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Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology

Posted 3 days ago in New Drug Approvals

JERUSALEM--(BUSINESS WIRE)--Jan. 18, 2017-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) approved Vantrela ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva’s proprietary abuse deterrence technology. Vantrela ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term o...

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FDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS Program

Posted 3 days ago in Pharma Industry News

January 18, 2017 -- The FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with...

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Heron Announces Submission of Cinvanti NDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)

Posted 5 days ago in New Drug Applications

SAN DIEGO--(BUSINESS WIRE)--Jan. 12, 2017-- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on developing novel best-in-class treatment solutions to address some of the biggest unmet patient needs, today announced submission of the New Drug Application (NDA) for Cinvanti (HTX-019), the first polysorbate 80-free, intravenous formulation of aprepitant for the prevention of...

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U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment

Posted 8 days ago in New Drug Applications

INDIANAPOLIS, Jan. 13, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to...

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U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab

Posted 9 days ago in New Drug Applications

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to...

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FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain

Posted 12 days ago in New Drug Approvals

WAYNE, Penn., Jan. 9, 2017 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved Arymo ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain...

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Alcobra Provides Update on Recent FDA Meeting and Path Forward for MDX Clinical Development Program

Posted 12 days ago in New Drug Applications

TEL AVIV, Israel, Jan. 09, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, received official minutes from its meeting with the Division of Psychiatry Products of the U.S. Food and Drug Administration (FDA)...

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AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain

Posted 13 days ago in New Drug Applications

REDWOOD CITY, Calif., Jan. 8, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, provided guidance today on 2017 milestones for its lead product, ARX-04, known as DSUVIA™ (sufentanil sublingual tablet, 30 mcg) in the United States. Specifically, AcelRx's c...

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FDA Approves Genentech’s Lucentis (ranibizumab) for Myopic Choroidal Neovascularization

Posted 2 weeks ago in New Drug Approvals

South San Francisco, CA -- January 5, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved ...

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Monthly News Roundup - December 2016

Posted 3 weeks ago in Pharma Industry News

Biogen’s Spinraza Approved for Spinal Muscular Atrophy The U.S. Food and Drug Administration (FDA) has cleared Biogen's Spinraza (nusinersen), the first drug for spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is classified as a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide and alters the splicing of the SMN2 gene to yield a...

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Monthly News Roundup - November 2016

Posted 7 weeks ago in Pharma Industry News

Novo Nordisk’s Xultophy 100/3.6 FDA-Approved for Type 2 Diabetes This month the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec (Tresiba), and the glucagon-like peptide-1 (GLP-1) agonist liraglutide (Victoza), used with diet and exercise to improve blood sugar control in type 2 diabetes. Xultophy is use...

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Monthly News Roundup - October 2016

Posted 11 weeks ago in Pharma Industry News

Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and who are at high risk for CDI recurrence. Zinplava is not an antibacterial and does not treat an active CDI infection. Zinplava is a human monoclonal antibody that b...

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Monthly News Roundup - September 2016

Posted 16 weeks ago in Pharma Industry News

Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ...

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Allergan and Gedeon Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids

Posted 4 days ago in Clinical Trials

DUBLIN and BUDAPEST, Hungary, Jan. 17, 2017 /PRNewswire/ -- Allergan Plc (NYSE: AGN) and Gedeon Richter Plc. today announced positive results from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids. A new drug application filing for ulipristal acetate is planned for the second half of...

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Tetraphase Pharmaceuticals Doses First Patient In IGNITE3 Phase 3 Clinical Trial of Once-Daily IV Eravacycline in cUTI

Posted 4 days ago in Clinical Trials

WATERTOWN, Mass., Jan. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced dosing of the first patient in IGNITE3, the Company's phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem in complicated urinary tract infections (cUTI). Eravacycline is a novel antibiotic candidate with potent activity against...

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Sunovion Announces Pivotal Study Results for Novel Drug Candidate Dasotraline Demonstrating Significantly Improved Attention Deficit Hyperactivity Disorder Symptoms in Children Compared to Placebo

Posted 7 days ago in Clinical Trials

MARLBOROUGH, Mass. January 14, 2017 --(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that results of a pivotal Phase 2/3 study (SEP360-202) evaluating novel drug candidate dasotraline in children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD) showed statistically significant improvement in the 4mg/day dose arm compared to placebo. The 2mg/day dose arm did not...

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Shionogi Announces Positive Top-Line Results For Cefiderocol Pivotal cUTI Clinical Trial

Posted 8 days ago in Clinical Trials

OSAKA, Japan and FLORHAM PARK, N.J., Jan. 12, 2017 /PRNewswire/ -- Shionogi & Co., Ltd. (hereafter "Shionogi") has announced that cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for non-inferiority vs imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria....

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VivaGel BV granted QIDP and Fast Track designation by US FDA

Posted 9 days ago in Clinical Trials

Melbourne, Australia; 12 January 2017: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel® BV by the US Food and Drug Administration (FDA). QIDP and Fast Track designations were granted independently for both the VivaGel® BV treatment and prevention indications for bacterial vaginosis (BV). This p...

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